U.S. patent number 5,120,321 [Application Number 07/540,139] was granted by the patent office on 1992-06-09 for safety disposable needle.
Invention is credited to Joseph Eisner, Henry C. Oksman.
United States Patent |
5,120,321 |
Oksman , et al. |
June 9, 1992 |
Safety disposable needle
Abstract
A safety disposable needle has a shroud with a canted bore
region slidably mounted thereon. A face of the shroud directed to
engage the skin has an adhesive coating for fixing the shroud to
the skin as the needle is withdrawn and its tip enters the shroud
after which the shroud is separated from the skin as it engages an
enlargement on the needle and is then canted to entrap the needle
tip.
Inventors: |
Oksman; Henry C. (Mamaroneck,
NY), Eisner; Joseph (New York, NY) |
Family
ID: |
24154181 |
Appl.
No.: |
07/540,139 |
Filed: |
June 19, 1990 |
Current U.S.
Class: |
604/198;
604/263 |
Current CPC
Class: |
A61M
5/3273 (20130101); A61M 2005/3249 (20130101) |
Current International
Class: |
A61M
5/32 (20060101); A61M 005/32 () |
Field of
Search: |
;604/192,197,198,263 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2209470 |
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May 1989 |
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GB |
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8900865 |
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Feb 1989 |
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WO |
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Primary Examiner: Rosenbaum; C. Fred
Assistant Examiner: Finkel; Sharon
Attorney, Agent or Firm: Mandelbaum; Howard F.
Claims
What is claimed is:
1. An improved apparatus for passing a fluid through the skin of a
living being, having a reservoir for storing and supplying said
fluid and a hollow tubular needle with a reservoir end connected to
one end of said reservoir and an opposite penetrating end for
penetrating the skin, wherein the improvement comprises
a shroud axially slidably mounted on said needle for movement
between a first position at which said penetrating end of said
needle is exposed and a second position at which said penetrating
end of said needle is covered by said shroud, said shroud having a
bore therethrough, said needle being slidably received in said bore
and in frictional engagement with said shroud at narrowed spaced
regions of said shroud respectively proximal to and distal from
said reservoir when in said first position, the axis of said bore
at said proximal region being out of alignment with the axis of
said bore at said distal region so that when said shroud is in said
second position the axis of said bore at said distal region is out
of alignment with the axis of said needle thereby preventing said
shroud from returning to said first position.
2. An improved apparatus according to claim 1 further comprising
skin adhesion means on said shroud for releasably securing said
shroud to the skin whereby said shroud is urged from said first
position to said second position as said needle is withdrawn from
the skin.
3. An improved apparatus according to claim 2 wherein said adhesion
means comprises a tacky element.
4. An improved apparatus according to claim 1 further comprising
limiter means mounted on at least one of said reservoir and said
needle and engageable with said shroud at said second position for
preventing said shroud from separating from said needle.
5. An improved apparatus according to claim 4 wherein said limiter
means comprises an enlargement on said needle intermediate its ends
and said shroud bore has a region intermediate said reservoir and
said needle enlargement narrower than said enlargement whereat said
enlargement is engaged by said shroud for preventing said shroud
from sliding beyond said second position.
6. An improved apparatus according to claim 1 wherein said
reservoir comprises a syringe.
7. A method of protecting against inadvertent puncture by a needle
after it has penetrated and been withdrawn from the skin of a
living being comprising
axially slidably mounting a shroud on said needle for movement
between a first position at which said penetrating end of said
needle is exposed and a second position at which said penetrating
end of said needle is covered by said shroud, and
supporting said shroud on said needle when in said first position
at misaligned bore portions respectively proximal to and distal
from said reservoir for forcing said shroud distal bore portion out
of alignment with said needle when said shroud is in said second
position.
8. A method of protecting against inadvertent puncture by a used
needle according to claim 7 further comprising limiting movement of
said shroud with respect to said needle to prevent said shroud from
separating from said needle after said needle tip is covered by
said shroud.
9. A method of protecting against inadvertent puncture by a used
needle according to claim 7 further comprising adhering said shroud
to the skin before said needle is withdrawn therefrom whereby said
shroud is slid over the tip of said needle as it is withdrawn.
Description
BACKGROUND OF THE INVENTION
Although exposed used syringe and intravenous needles have always
presented a danger of transmitting infectious disease, the recent
and highly publicized alarming spread of AIDS virus has focused
attention on the problem. Whereas the possibility of an accidental
engagement with the end of a used syringe or intravenous needle may
have once been considered a minor annoyance associated with a pin
prick, physicians, nurses, and other hospital and medical office
personnel are now aware that their very lives are threatened by the
existence of used syringe and intravenous needles which have not
been properly discarded. In the course of a lawsuit recently given
high notoriety, it was alleged that a physician contracted AIDS by
accidentally pricking herself with a needle carelessly left among
the bed sheets of an infected patient who had been injected with
the needle.
The need for making a needle safe after use is well known but none
of the solutions proposed to date adequately addresses the problem.
In order to be effective, such a solution must be economical, that
is, it must not unduly increase the cost of a syringe or
intravenous needle assembly which is a high volume disposable item.
Protection of the used needle must also be automatic so as to avoid
compromise of safety by human error.
Proposed devices of the prior art fail to meet the foregoing
criteria. For example, U.S. Pat. No. 4,790,828 to Dombrowski et al.
for a Self-Capping Needle Assembly discloses a syringe with a
relatively complex cap member having moving parts and projections
that must be squeezed together to move the protective part of the
cap member over the tip of the needle. U.S. Pat. No. 4,861,338 to
Mathiesen et al. for a Safety Syringe is directed to a device for
retracting the syringe needle into a sheath much like the writing
cartridge of a ball point pen is retracted into the barrel of the
pen. The foregoing devices of the prior art are relatively
expensive and complex and their designs require the intervention of
the physician, nurse or technician using the syringe or intravenous
device to make the used needle safe.
SUMMARY OF THE INVENTION
The present invention overcomes the aforementioned disadvantages of
the prior art by providing an apparatus and method for protecting
against the tip of a used syringe or intravenous needle which is
cost effective and requires no user intervention.
More specifically, the instant invention provides an apparatus and
method for passing a fluid through the skin of a living being from
a reservoir for storing or receiving the fluid, a hollow tubular
needle with a reservoir end mounted on one end of the reservoir and
an opposite penetrating end for penetrating the skin, a shroud
axially slidably mounted on the needle for movement between a first
position at which the penetrating end of the needle is exposed and
a second position at which the penetrating end of the needle is
covered by the shroud, the shroud having a hollow bore through
which the needle completely extends when the shroud is in the first
position, and an adhesive on its surface for releasably affixing
the shroud to the skin, and the needle having an enlargement
intermediate its ends larger than a narrowed region of the bore in
the shroud for preventing the shroud from sliding entirely off the
needle, whereby the shroud, when in the first position, exposes the
penetrating end of the needle and engages the skin at the adhesive
surface when the needle is inserted therein, and the shroud adheres
to the skin while the needle is withdrawn therefrom for causing the
shroud to slide over the penetrating end of the needle whereat the
needle enlargement is engaged in the narrowed bore region of the
shroud in the second position thereby causing the shroud to
separate from the skin as withdrawal of the needle continues.
It is therefore an object of the invention to provide an apparatus
and method for covering the tip of a syringe or intravenous needle
after use.
Another object of the invention is to provide an apparatus and
method for automatically covering the tip of a syringe or
intravenous needle after use.
Still another object of the invention is to provide an apparatus
and method for covering the tip of a syringe or intravenous needle
after use by a device which can be employed at minimal cost.
Still a further object of the invention is to provide an apparatus
and method for covering the tip of a syringe or intravenous needle
after use which is reliable and cannot be readily undone.
Other and further objects of the invention will be apparent from
the following drawings and description of a preferred embodiment of
the invention in which like reference numerals are used to indicate
like parts in the various views.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is an elevation view of the apparatus of the preferred
embodiment of the invention in an initial disposition.
FIG. 2 is a fragmentary enlarged elevation view of the apparatus of
the preferred embodiment of the invention in the disposition of
FIG. 1.
FIG. 3 is an elevation view of the apparatus of the preferred
embodiment of the invention in an intermediate disposition.
FIG. 4 is a fragmentary enlarged elevation view of the apparatus of
the preferred embodiment of the invention in a final
disposition.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to the drawings, there is shown a syringe 1 having an
elongated hollow cylindrical reservoir 3 terminating at one end in
a frustoconical portion 5. Slidably disposed in the reservoir 3 is
a cylindrical plunger 7 with an enlarged thumb button 9 for
pressing the plunger into the reservoir 7 to increase pressure on a
fluid in the form of medication stored therein for injection, or
for pulling the plunger out of the reservoir body to decrease
pressure in the reservoir for filling the reservoir with a fluid,
e.g., a medication stored in a bottle or blood or other body fluid
drawn from a patient. The syringe reservoir 3 and plunger 7 are
conventional.
Affixed to the frustoconical end of the syringe reservoir 7 is a
hollow tubular needle 11 having a tip 13 capable of penetrating the
skin of a living body. Intermediate the end of the needle 13
attached to the frustoconical end 5 of the syringe reservoir 3 and
the tip 13 of the needle 11 is a limiter for preventing movement of
the shroud 19 completely over the tip 13 and off the needle 11, in
the form of an enlargement 17. The enlargement 17 should typically
have an outer diameter on the order of ten to twenty per cent
(10%-20%) of the outer diameter of needle 11 if the enlargement 17
is to be on a portion of the needle that enters the skin as shown
in FIGS. 1 and 2. The enlargement 17 is shown in exaggerated size
in the drawings for visibility. The enlargement 17 can be formed in
a number of ways, e.g., by bulging the needle 11, by bending or
crimping the needle 11, or by affixing a narrow circumferential
band to the exterior of the needle 11.
Slidably disposed on the needle 11, as best seen in FIGS. 2 and 4,
is a shroud in the form of a hollow cylindrical plug 19 having a
substantially cylindrical stepped bore 21. The plug 19 need not be
cylindrical but can have numerous other shapes including, without
limitation, conical, C-shaped, spherical, rectangular, pyramidal,
or almost any other shape which will have a surface able to adhere
to the skin as will be more fully explained below. The plug 19 is
preferably formed from a light weight semi-rigid elastomeric
plastic or rubber material. At the end of the shroud 19 proximate
the frustoconical end 5 of the syringe reservoir 3 the bore has a
region 23 that is so narrow as to slidably frictionally engage the
exterior of the needle 11, and preferably canted slightly, as shown
in FIGS. 2 and 4, to aid friction and to help entrap the needle tip
13 within the bore 21 after the needle is used as will be more
fully explained below.
Other means may be employed to apply friction to the needle as the
plug 19 is slid along its length. For example, a resilient ball, or
a spring, or a ball and spring may be partially recessed within a
wall of the plug 19 in or adjacent the bore region 23.
The canted narrow bore region 23 leads into an enlarged bore region
25 which is desirably several times greater than the thickness of
the needle 11. Finally the enlarged bore region 25 terminates in a
narrow region 27 which frictionally slidably engages the exterior
of the needle 11 when the needle 11 is disposed in the narrow bore
region 27. Friction between the needle 11 and the inner wall of the
shroud 19 takes place in the bore regions 23 and 27 and is enhanced
by the canting of the bore region 23 in engagement with the needle
11. The bore region 27 is larger than the bore region 23 and,
unlike the bore region 23, is large enough to pass the enlargement
17.
Coated onto the surface 29 of the shroud 19 which faces in
substantially the same direction as the tip 13 of the needle 11 is
a layer of an adhesive 31. The adhesive 31 is one that can
removably affix to the skin such as a tacky cement of the type
commonly used on surgical tape for bandages. The adhesive 31 is
selected and applied over a large enough surface of the shroud 19
so as to adhere to the skin with a force greater than the
frictional force between the shroud 19 and the needle 11. The
exposed face of the adhesive may be covered with a protective
releasable strip (not shown) that can be peeled away and discarded
immediately prior to use of the syringe 1.
Referring now specifically to FIG. 1, the syringe 1 is shown with
the needle 11 fully inserted into the skin 15 of a living being. In
this disposition, the shroud 19 is in a first position adjacent the
frustoconical end 5 of the syringe reservoir 3 with its surface 29
fixed by the adhesive 31 to the skin 15. As can be seen in FIG. 2,
there is sufficient extension of the needle 11 beyond the shroud 19
to permit sufficient penetration of the needle tip 13 into the skin
15 for an injection or withdrawal of body fluid.
Although FIG. 2 shows the needle in a position transverse to the
surface of the skin as is often the practice when a serum is
injected into a patient, the needle may penetrate at an angle
oblique to the skin surface, as is frequently the practice when
blood is drawn or a fluid is administered intravenously. It is only
necessary that the surface of the shroud which will engage the skin
when the needle is inserted be provided with the adhesive.
Upon completion of the injection or withdrawal of body fluid, the
syringe 1 with needle 11 is withdrawn from the skin while the
shroud 19 remains affixed to the skin, as shown in FIG. 3, until
the tip 13 of the needle 11 passes completely through the narrow
bore region 27 in the shroud 19 and enters the enlarged bore region
25. Once the tip 13 of the needle 11 enters the enlarged bore
region 25 the needle 11 can be readily canted with respect to the
shroud 19
As the syringe 1 with needle 11 is withdrawn from the skin 15,
enlargement 17 engages the interior wall of the shroud 19 where the
enlarged bore region 25 meets the canted narrow bore region 23.
Because the bore region 23 is smaller than the enlargement 17 on
the needle 11, the enlargement 17 pulls against the shroud 19 as
the syringe 1 and needle 11 are further withdrawn thereby breaking
the bond between the adhesive 31 and skin 15 and pulling the shroud
19 away from the skin 15.
Once the shroud 11 is free of the skin 15 with the tip 13 of the
needle 11 within the enlarged bore region 25, the canted bore
region 23 is urged to align with the needle 11 thereby canting the
shroud 19 so that the tip 13 of the needle 11 is entrapped within
the shroud 19 as shown in FIG. 4. In this position, the needle 11
is safe as its tip 13 is fully covered by the shroud 19 and
inaccessible.
It is to be appreciated that the foregoing is a description of a
preferred embodiment of the invention to which variations and
modifications may be made without departing from the spirit and
scope of the invention. For example, instead of the reservoir being
contained within a syringe, the reservoir may be an intravenous
bottle or bag connected to a needle through flexible tubing.
Moreover, no reservoir is necessary as any needle or puncturing
device adapted to penetrate the skin, which can thereafter carry
infectious organisms, can be protected after use in accordance with
the teachings of the invention.
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